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EXTERNAL SLT Treatment in Patients With Uncontrolled OPEN ANGLE GLAUCOMA (ETSG)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01384149
First received: May 16, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to evaluate the advantages and disadvantages of external selective laser trabeculoplasty (SLT) in treating open angle glaucoma,compared to traditional SLT.


Condition Intervention Phase
Primary Open Angle Glaucoma
Device: external slt
Device: standard slt
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pioneer Study: External Selective Laser Trabeculoplasty for Treating Uncontrolled Open Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Intra Ocular Pressure values as a measure for treatment success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    a success is defined a decrease of >/= 20% in intra ocular pressure measured after treatment -compared to intra ocular pressure measured prior to treatment a relative success in an intra ocular pressure thet is lowered post treatment in less than 20% -compared to pre-treatment. failure is considered as an intra ocular pressure equal or higher than measured prior to treatment


Secondary Outcome Measures:
  • Use of supplementary treatment for lowering intraocular pressure [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    success is defined as no need for suplemental medication for lowering intra ocular pressure ,complete failure is described as using the same amount or more of medication ,relative success in described as a need to use less hypotensive medications for lowering intraocular pressure after the procedure


Enrollment: 32
Study Start Date: September 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standart slt
gonioscopic selective laser trabeculoplasty
Device: standard slt
Nd:YAG LASER SLT gonioscopic laser treatment
Other Name: SLT laser
Experimental: external slt
perilimbal ,above trabecular meshwork 180 degrees ,100 laser dots
Device: external slt
Nd:YAG LASER SLT perilimbal above trabecular meshwork 180 degrees ,100 lasering dots
Other Name: external SLT laser

Detailed Description:

glaucoma is the 2nd leading cause for blindness in the western world.at the time approximately 60 million people are diagnosed as glaucoma patients with an estimated rise of 30% in the next decade. glaucoma is defined as a progressive damage to the optic nerve ,followed by a damage to the visual field. high intraocular pressure (IOP) is considered a main risk factor.lowering IOP can be done in several ways ,including medication ,laser treatment and operations.

medical treatment is effective in most cases ,but requires high daily compliance,side effects and availability of medication in living areas.

laser trabeculoplasty treatment for reducing IOP is a first line treatment for patients with open angle glaucoma (OAG).with success rate of 70-90%, it can be done as an additive treatment or as a sole treatment.

SLT or "cold" laser is a non-invasive treatment in which short wave lengths are being transduced in short intervals ,through a gonioscopic lens to the area of filtering angle. thec wave length is specific to cells rich in melanin (located in the filtering angle). the mechanism of action is regeneration of cytokine surge -causing macrophages recruitment and breakage of inter-cell connections at the trabecular meshwork (filtering area) and allows rise in fluid shift. the treatment requires several lasering to areas at the surrounding the wave does not cause rise in tissue heat or scaring of tissue and can be repeated.among its disadvantages are reduction in affect during time,causing new elevation of IOP , potential peripheral anterior synechia (PAS), corneal erosion or oedema,requires experience in treating through gonioscopic lense.

previous reports in the literature regarding external low intensity laser (LIL)show less complication rate.

our study evaluates the use of external SLT by using a standard retinal laser machine ,with procedure performed on the outer sclera-above the trabecular meshwork with laser parameters similar to those used in retinal surgeries.

this is a prospective, randomized, comparative clinical trial.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary Open Angle Glaucoma
  • clinical appearance of pigment at the angle
  • angle assessed as >3 by a professional glaucoma expert
  • IOP above target pressure under full anti-hypertensive treatment with a good compliance for treatment or IOP above target pressure and poor compliance to medical treatment due to: allergic reaction , side effects,physical inability etc.
  • able to sign independently on an informed concent

Exclusion Criteria:

  • pregnancy/breast feeding
  • glaucoma not specified as primary open angle glaucoma
  • sensitivity to on or more of the medications in the study
  • current /past intraocular inflammation
  • primary open angle glaucoma with out appearance of pigment at the angle
  • s/p laser trabeculoplasty at treatment eye
  • inability to sign an informed concent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384149

Locations
Israel
Assaf Harofhe Medical Center
Beer Yaakov, Israel, 70300
Ophthalmology Department ,Meir Medical Center
Kfar Saba, Israel, 44281
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Meir Medical Center
Investigators
Study Chair: Noa Gefen, Dr. Meir Medical Center, Kfar Saba, Israel
Principal Investigator: Michael Belkin, Prof. Sheba Medical Center, Ramat Gan ,Israel
Principal Investigator: Ehud Asia, Prof. Meir Medical Center, Kfar Saba, Israel
Principal Investigator: Audry masas-kaplan, Dr. Assaf Harofhe Medical Center, Beer Yaakov, Israel
  More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01384149     History of Changes
Other Study ID Numbers: meirslt2011
Study First Received: May 16, 2011
Last Updated: August 11, 2014
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
Israel: Ethics Commission

Keywords provided by Meir Medical Center:
intra ocular pressure
open angle glaucoma
selective laser trabeculoplasty
external laser treatment

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 20, 2014